Evaluate Efficacy and Safety of Extended Adjuvant Treatment With Letrozole in Postmenopausal Women With Hormone Receptor Positive Breast Cancer Who Have Completed 5 Years of Toremifene
1. Primary purpose To evaluate disease free survival rate (DFS) after taking 36 months
with Letrozole in postmenopausal women with hormone receptor positive breast cancer who
complete 5 years of Toremifene
2. Secondary purpose
- To evaluate follows after taking 36 months with Letrozole in postmenopausal women
with hormone receptor positive breast cancer who complete 5 years of Toremifene.
1. Disease Free Survival rate(DFS)-12 months, 24 months
2. Distant disease free survival rate(DDFS), Overall Survival(OS)
- 12 months, 24 months, 36 months c. safety
- Change of lipid profiles
- Mortality and morbidity due to Cardiovascular disease
- Incidence of Fracture
- Change of Bone density
- Common toxic effect
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Disease free survival rate
3 years
Yes
Sei-Hyun Ahn, MD
Principal Investigator
Department of Surgery, Asan medical center, South Korea
Korea: Food and Drug Administration
KBCSG007
NCT01072318
January 2010
January 2014
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